Intracranial AneurysmNCT06158750
To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
A study testing p64/p48 MW HPC Flow Modulation Device in people with Intracranial Aneurysm, run by Shanghai Wallaby Medical Technologies Co.,Inc. at 1 site in China.
Trial summary
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- p64/p48 MW HPC Flow Modulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 80 years, male or female;
- Patients diagnosed as intracranial aneurysms by brain CTA/MRA/DSA;
- Patients with unruptured saccular aneurysms or fusiform aneurysm who are clinically determined to use flow modulation device for endovascular treatment;
- The diameter of the target aneurysm parent vessel was 1.75-5mm;
- Patients target aneurysm is planned to be embolized using flow modulation devices only;
- The mRS Score of the patients was 0-2
- Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.
Who cannot join
- Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment;
- Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography;
- Patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery;
- Patients with target aneurysm treated with endovascular interventional therapy before enrollment;
- Known to be allergic to Nitinol platinum alloy and angiographic agents;
- Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation;
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- The target aneurysms were blood vesicular aneurysms, pseudoaneurysms, or aneurysms associated with arteriovenous malformation, moyamoya disease, or multiple aneurysms that could not be treated by a single flow modulation device;
- Serious infection is not controlled and is not suitable for operation;
- Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;
- Obvious abnormal coagulation function or bleeding tendency;
- Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;
- Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;
- Participation in any other clinical trial within 30 days prior to signing informed consent;
- Other conditions considered by the investigator to be inappropriate for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Hongqi Zhang, +86 10 8392 2345, gcp@conlifemed.com
About this study
Official title: A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Read the detailed description
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
- Conditions
- Intracranial Aneurysm
- Being tested
- p64/p48 MW HPC Flow Modulation Device
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p64/p48 MW HPC Flow Modulation DeviceDevice
Endovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use Flow modulation device to treat intracranial aneurysm. Receives: Device: p64/p48 MW HPC Flow Modulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated.
Aneurysm complete occlusion is defined as Raymond Grade I.
Measured: 12 months
Secondary outcomes (7)
Technical success rate
Technical success is defined as the successful placement of a Flow Modulation Device. Successful implantation means that the Flow Modulation Device is placed at the target site and effectively covers the neck of the aneurysm, and the rest of the device is successfully released and withdrawn to the outside of the body.
Measured: Within 24 hours after surgery
Rate of successful occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months and 12 months after surgery according to the subjects' imaging results, and the rate of successful aneurysm occlusion was calculated.
Aneurysm successful occlusion is defined as Raymond Grade I/II.
Measured: 6 months, 12 months
Rate of complete occlusion
Raymond grade was evaluated by the independent imaging evaluation Committee 6 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated.
Aneurysm complete occlusion is defined as Raymond Grade I.
Measured: 6 months
Rate of good clinical prognosis
Good clinical prognosis means mRS 0~2
Measured: 3 months, 6 months, 12 months
Rate of in-stent-stenosis
In-stent-stenosis defined as moderate or severe stenosis of the tumor artery, that is, stenosis > 50%
Measured: to 6 months, to 12 months
Device performance evaluation
After each use of the device, the researchers evaluated the operational performance of the device in terms of conveying, flexibility, compliance and wall adhesion.
Measured: Within 24 hours after surgery
Death, stroke, and thrombotic events
Record the number of death, stroke and thrombotic events throughout the clinical trial period.
Measured: to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start17 Nov 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
- Responsible party
- Sponsor
- Investigators
- Hongqi Zhang, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158750
- Sponsor's protocol ID
- TP-1312
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT06158750
- Acronym / sponsor ID
- TP-1312
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Wallaby Medical Technologies Co.,Inc.Industry (pharma, biotech, devices)
- Collaborators
- Phenox GmbH, Beijing Wallaby Medical Technologies Co.,Inc.
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Detailed description
Title: A prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of Flow Modulation Device for intracranial aneurysms.
Device: p64/p48 MW HPC Flow Modulation Device. Study design: Prospective, multicenter, single arm Clinical Study.
Purpose: To assess safety and effectiveness of p64/p48 MW HPC Flow Modulation Device .
Study duration: 32 months. Sample Size: 120 patients. Number of sites: ≤10. Follow-up time: 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: p64/p48 MW HPC Flow Modulation DevicePatients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use Flow modulation device to treat intracranial aneurysm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged from 18 to 80 years, male or female;
- Patients diagnosed as intracranial aneurysms by brain CTA/MRA/DSA;
- Patients with unruptured saccular aneurysms or fusiform aneurysm who are clinically determined to use flow modulation device for endovascular treatment;
- The diameter of the target aneurysm parent vessel was 1.75-5mm;
- Patients target aneurysm is planned to be embolized using flow modulation devices only;
Key exclusion criteria (14 listed)
- Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment;
- Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography;
- Patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery;
- Patients with target aneurysm treated with endovascular interventional therapy before enrollment;
- Known to be allergic to Nitinol platinum alloy and angiographic agents;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p64/p48 MW HPC Flow Modulation DeviceEndovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms | Device | Test group |
Primary outcome
Rate of complete occlusion
Time frame: 12 months
Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.
7 secondary outcomes
Technical success rate
Time frame: Within 24 hours after surgery
Rate of successful occlusion
Time frame: 6 months, 12 months
Rate of complete occlusion
Time frame: 6 months
Rate of good clinical prognosis
Time frame: 3 months, 6 months, 12 months
Rate of in-stent-stenosis
Time frame: to 6 months, to 12 months
Device performance evaluation
Time frame: Within 24 hours after surgery
Death, stroke, and thrombotic events
Time frame: to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongqi Zhang principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing p64/p48 MW HPC Flow Modulation Device in people with Intracranial Aneurysm, run by Shanghai Wallaby Medical Technologies Co.,Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenwen Jia (+86 18818201005, Wendy.Jia@wallabyphenox.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complete occlusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.